Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-03-2020

Publisher

British Standards Institution

This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. AnnexA describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

Committee	CH/194
DevelopmentNote	Supersedes 96/560211 DC. (11/2005) Supersedes 08/30187781 DC. (03/2010) Supersedes 16/30335531 DC. (01/2018)
DocumentType	Standard
Pages	28
ProductNote	Annexes ZA and ZB added
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN ISO 10993-16:2010

Standards	Relationship
DIN EN ISO 10993-16:2016-04 (Draft)	Identical
SN EN ISO 10993-16 : 2010	Identical
UNI EN ISO 10993-16 : 2010	Identical
NBN EN ISO 10993-16 : 2010	Identical
I.S. EN ISO 10993-16:2010	Identical
ISO 10993-16:2017	Identical
EN ISO 10993-16:2017	Identical
DIN EN ISO 10993-16 E : 2010	Identical
UNE-EN ISO 10993-16:2010	Identical

ISO/TR 10993-22:2017	Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-18:2005	Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO 10993-12:2012	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14971:2007	Medical devices Application of risk management to medical devices